Investigate the effect and mechanism of time-restricted eating (TRE) on the clinical pregnancy rate in women with PCOS and glucose metabolism disorder via IVF/ ICSI.
In this multicenter randomized controlled study, investigators plan to recruit 254 patients, aged 20-38, with PCOS and glucose metabolism disorder. PCOS diagnostic criteria based on Rotterdam 2003 criteria, glucose metabolism disorder are diagnosed by 1998 WHO diagnostic criteria, with HbA1c≤7%. Participants selected are overweight or obese (24Kg/m2 ≤ BMI ≤40Kg/m2), and are planned to start the 1st/ 2nd cycle of IVF/ ICSI. Investigators divide these patients randomly into 2 groups (each group with 127 patients): metformin only group (control group) and TRE with metformin group. Every participant receives the specific treatment according to the group for at least 6 weeks. During the intervention period, follow-ups, blood chemistry tests and examinations are recorded every 2 weeks. After the intervention period, IVF/ ICSI is carried out. GnRH-agonist- or/and hCG-triggered is used for ovarian stimulation. Ovum retrieval will be carried out 34-36h after ovarian stimulation. Blood hCG is tested after 12-14 days after embryonic transfer. For patients with positive hCG, clinical pregnancy is confirmed by observing gestational sac via transvaginal ultrasound after 4-5 weeks. Investigators compare the terminal pregnancy-related result and metabolic changes between 2 groups to determine the effect and the possible mechanisms of TRE on IVF/ ICSI clinical pregnancy rate of PCOS with glucose metabolism disorder patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
254
TRE (eating is allowed from 8am to 4pm without limitation in calories) with metformin 1g bid po for 6 weeks
Taking metformin 1g bid po only for 6 weeks as control
RenJi Hospital Department of Endocrinology and Metabolism
Shanghai, Shanghai Municipality, China
Clinical pregnancy rate for the first embryo transfer
Clinical pregnancy rate= (number of cycle for 1or more gestational sac is observed via transvaginal ultrasound/ total number of cycle for first embryo transfer)x100%
Time frame: 4-5 weeks after the IVF/ ICSI carried out at the end of the 6 weeks intervention
Number of retrieved oocytes
Includes immature oocytes, mature oocytes and abnormal oocytes from ovum pick-up
Time frame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Implantation rate
the ration of total number of early gestational sacs to total number of transferred embryos
Time frame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Abortion rate
the ratio of the number of nonviable pregnancies before 28 weeks of gestation to the number of clinical pregnancies
Time frame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Number of good quality embryo
Day 3 embryo with 7-9 cells and \<10% fragmentation
Time frame: After the IVF/ ICSI carried out at the end of the 6 weeks intervention
Weight
Weight change in kg
Time frame: From enrollment to the end of treatment at 6 weeks
Fat%
Inbody machine measurement
Time frame: From enrollment to the end of treatment at 6 weeks
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Lipid profile
Triglycerol, total cholesterol, HDL, LDL, free fatty acid in mmol/L
Time frame: From enrollment to the end of treatment at 6 weeks
Blood pressure
Both systolic and diastolic pressure in mmHg
Time frame: From enrollment to the end of treatment at 6 weeks
Sex hormone
DHEAs, testosterone, androstadienone, estradiol, LH, FSH, progesterone, prolactin, SHBG
Time frame: From enrollment to the end of treatment at 6 weeks
OGTT
Blood glucose level at 0h, 1h, 2h in mmol/L
Time frame: From enrollment to the end of treatment at 6 weeks
Insulin stimulation
Serum insulin level at 0h, 1h, 2h in ng/ml
Time frame: From enrollment to the end of treatment at 6 weeks